Last week, U.S. Senators warned hospitals that higher rates of back surgery may indicate a kickback if the purchase of spinal devices has increased as a result of physician ownership of device distributors.  Senators Orrin Hatch (R-Utah), Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) issued the bipartisan statement based on an HHS report that showed a direct correlation between…

CMS continues to emphasize readmissions as a marker of quality.  CMS research shows that approximately 45% of hospital admissions among those receiving either Medicare skilled nursing services or Medicaid skilled nursing services could have been avoided.  Husch Blackwell attorneys Mark Chouteau and Michael Crowe recently authored an article in the October issue of AHLA Connections…

In late February of this year, an employee at an independent living facility in Bakersfield, California was asked by a 911 dispatcher to begin CPR on an 87-year-old resident.  Despite the 911 dispatcher’s pleas, the employee refused.  The employee was allegedly following a facility policy that, in the event of a health emergency, the staff is to immediately call EMS for assistance and wait with the resident. The residents are informed of and agree to this policy on admission. The resident ultimately passed away.  Although the resident’s family expressed satisfaction with the manner in which the facility handled the situation, the situation generated a great deal of negative publicity. This situation also caused many assisted living facilities (“ALFs”) to question whether they are required to provide CPR. Unlike skilled nursing facilities, ALFs provide a lower level of care to their residents and often do not have nursing personnel on staff 24-hours per day.

The answer to the question of whether an ALF can have a policy like the one at issue in the California situation depends largely on state law.  At least 18 states have explicit laws requiring CPR-trained staff members in ALFs.  Oregon recommends CPR training, but does not require it.  Montana law provides that CPR-trained staff need only be on duty if the facility offers CPR, impliedly authorizing a “no-CPR” policy.  Kentucky is similar but more explicit:  ALFs must train staff on CPR “unless the policies of the [ALF] state that this procedure is not initiated by its staff….” 

As the government shutdown drags on, some CMS activities are grinding to a halt. CMS recently released a memo to State Survey Agency Directors regarding which CMS survey and certification activities will continue and which ones have been put on hold for providers of all types. According to the memo, complaints that are triaged as…

Last week, our own Brian Bewley chaired the HCCA Midwest Regional Conference in Overland Park, Kansas.  The conference addressed current compliance issues such as the compliance officer’s evolving role, RAC audits and appeals, and HIPAA.  The conference had a great turnout – in fact, the most attendees in the conference’s history.

Husch Blackwell’s Julianne Story…

Pfizer, Inc. recently petitioned the Supreme Court, seeking review of three companion decisions from the First Circuit Court of Appeals.  These decisions found against Pfizer and in favor of multiple third-party payors (TPPs)—the Kaiser Foundation Health Plan, Inc. (an HMO), Aetna, Inc. (a health insurer), and a putative class of employer health plans—on civil Racketeer Influenced and Corrupt Organizations Act (RICO) claims for damages suffered due to Pfizer’s fraudulent marketing of off-label uses for the prescription drug Neurontin, an anti-convulsive approved for the treatment of epilepsy.  At the heart of the dispute is causation—the causal chain that runs from a drug manufacturer, such as Pfizer, to third-party payors of prescription drug benefits, such as HMOs, insurers and other health plans.

The First Circuit’s lead opinion—laying the common predicate necessary to understand each of the companion cases—came in the action brought against Pfizer by Kaiser, in which the court affirmed a $142 million jury award to the HMO.

The Development and Marketing of Neurontin

Neurontin was developed during the 1980s and early 1990s as an anti-epileptic drug.  In 1993, the Food and Drug Administration approved Neurontin for treatment of partial seizures in adults with epilepsy.  A campaign to market Neurontin for off-label conditions—conditions not included on the official label approved by the FDA—began in 1995.  These off-label conditions included neuropathic pain (pain from nerve damage), migraine headaches, and bipolar disorder.  Neurontin was marketed for treatment of these off-label conditions by way of, among other things:  (1) direct marketing to doctors, which misrepresented Neurontin’s effectiveness for off-label indications; (2) misleading information supplements and continuing medical education programs; and (3) articles published in medical journals that touted Neurontin’s off-label effectiveness but suppressed negative information about the drug. 

In response to healthcare reform, terms such as “physician alignment strategies” and “physician integration” have resurfaced in our vocabulary as healthcare providers.  In our new healthcare environment, many experts advocate that only hospitals that are aligned, or integrated, with their physician providers will be able to organize delivery systems that are capable of meeting current and future demands for efficiency, quality, price and services expected from patients and payers.  As the demands on health care providers continue to escalate, will experts also someday advocate that only hospitals that are aligned with other hospitals, or other health systems, be positioned to meet the then-current and future expectations related to providing high-quality and cost-efficient health care?

As the future of hospital and physician alignment strategies continue to evolve, more physicians, hospitals and health systems are affiliating.  Even large organizations such hospitals and health systems are teaming together to form loose associations in order to better manage the demands for efficiency, quality, price and service being thrust upon all providers by health reform, payers and patients.

There are a number of recent examples of health systems and hospitals forming strategic alignments to better manage healthcare costs and patient care. 

You have picked a strong trademark, had it searched and filed your intent to use application.  All went well and you have a trademark registration.  You have created your trademark usage manual. The marketing department has been advised to follow those guidelines and to use the ® symbol next to the mark in advertising.  You are doing everything right.

Is it time to just kick back and build brand equity?  No.

There are still a few additional issues you need to pay attention to.  One of these issues is maintenance of your trademark registration.  A trademark registration does not continue indefinitely.  It requires tending.

Declaration of Continued Use

A declaration of continued use (under § 8 of the Lanham Act) must be filed during the year preceding the 6th anniversary of the registration date. The declaration can also be filed within a 6 month grace period, upon payment of an additional fee.  It is also necessary to file a current specimen showing use of the mark.

Some employers may have rejoiced when IRS Notice 2013-45 delayed until 2015 the implementation of the employer shared-responsibility penalties mandated by the Patient Protection and Affordable Care Act (ACA). Certainly, this delay is a win for employers; however, other healthcare reforms will demand the attention of health plan sponsors before January 1, 2014.  Husch Blackwell…

Pursuant to the Affordable Care Act, the Centers for Medicare and Medicaid Services recently adopted a final rule implementing $1.1 billion in cuts to the Medicaid disproportionate share hospital (DSH) program in 2014 and 2015.  The new rule reduces Medicaid DSH payments by $500 million in 2014 and $600 million in 2015.　

There are several…